Talent.com
Senior Manager, Clinical Data Management

Senior Manager, Clinical Data Management

Bristol-Myers SquibbPrinceton Junction, NJ, US
12 hours ago
Job type
  • Full-time
  • Part-time
Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more : careers.bms.com / working-with-us .

Functional Area Description

Clinical Data Management key focus is to ensure data quality, integrity & completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database lock.

Position Summary

The Senior Manager, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role may report into Director, Clinical Data Management or Associate Director, Clinical Data Management

This is an office-based in BMS New Jersey locations.

Position Responsibilities

Responsibilities will include, but are not limited to :

Project Management and Leadership

  • Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
  • Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
  • Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members
  • Provides strong quality and project oversight over third party vendor responsible for data management deliverables
  • Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes
  • Authors, reviews / revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
  • Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness
  • Represents DM on cross-functional project teams & submission Teams
  • Lead or support the Health Authority inspections and audits
  • Provides coaching and quality oversight of junior Data Management Leads

FSP / CRO / Vendor Oversight

  • May act as core member of the study team and provides FSP / CRO / Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)
  • Continuous improvement initiatives

  • Provides the relevant support and input to continuous improvement activities within clinical data management
  • Provides support for CAPA implementation as required
  • Degree / Experience Requirements

  • Bachelor's Degree required with an advanced degree preferred
  • At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.
  • Key Competency Requirements

  • Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
  • Sound knowledge of Clinical Drug Development Process, FDA / ICH guidelines and industry standard practices regarding data management
  • Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
  • Strong project management; Exhibits expertise in metrics analysis and reporting methodologies
  • Excellent oral and written communication skills. Communicate effectively with senior management and cross-functional teams
  • Knowledge of submission requirements, [e.g. New Drug Application (NDA) / Biologics License Application (BLA) / Market Authorization Application (MAA)]
  • Travel Required : 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)

    If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

    Compensation Overview :

    Madison - Giralda - NJ - US : $143,590 - $173,998

    Princeton - NJ - US : $143,590 - $173,998

    The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

    Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https : / / careers.bms.com / life-at-bms / .

    Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility / infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

    Uniquely Interesting Work, Life-changing Careers

    With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

    On-site Protocol

    BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role :

    Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

    BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations / adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation / adjustment prior to accepting a job offer. If you require reasonable accommodations / adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com / eeo -accessibility to access our complete Equal Employment Opportunity statement.

    BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

    BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

    If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information : https : / / careers.bms.com / california-residents /

    Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

    Required

    Preferred

    Job Industries

  • Healthcare
  • Create a job alert for this search

    Manager Clinical Data • Princeton Junction, NJ, US

    Related jobs
    • Promoted
    Senior Manager, Clinical Data Management

    Senior Manager, Clinical Data Management

    Bristol Myers SquibbPrinceton, NJ, US
    Full-time
    Senior Manager, Clinical Data Management.Those aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens ...Show moreLast updated: 3 days ago
    • Promoted
    (Associate) Clinical Development Director

    (Associate) Clinical Development Director

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    As our Clinical Development Director in Cardiology you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data...Show moreLast updated: 24 days ago
    • Promoted
    Senior Manager Clinical Study Lead (Oncology)

    Senior Manager Clinical Study Lead (Oncology)

    RegeneronWarren, NJ, US
    Full-time
    This role is an onsite position in one of our office locations.The Senior Clinical Study Lead (CSL) is expected to operate with a high degree of independence and is accountable for the global execu...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Study Manager, Clinical Operations

    Senior Study Manager, Clinical Operations

    AequorPrinceton, NJ, US
    Full-time
    Organizes and facilitates the overall planning, coordination, tracking and general performance of clinical studies that support the Clinical Development Plan. The Senior Study Manager (SSM) is respo...Show moreLast updated: 30+ days ago
    • Promoted
    Clinical Product Manager, Measures Management (6 month contract)

    Clinical Product Manager, Measures Management (6 month contract)

    NeuroFlowPhiladelphia, PA, US
    Full-time +1
    Clinical Product Manager, Measures Management.NeuroFlow CEO and West Point graduate Christopher Molaro served in the army for five years, including a tour in Iraq as a platoon leader.Coming back ho...Show moreLast updated: 30+ days ago
    • Promoted
    Clinical Manager

    Clinical Manager

    Topaz HRLakewood, NJ, US
    Full-time
    We are seeking a highly motivated and experienced Clinical Manager to provide strong leadership and oversight to our team of board-certified behavior analysts (BCBAs) and ABA therapists.This is a p...Show moreLast updated: 30+ days ago
    • Promoted
    Clinical Director - Home Care - RN

    Clinical Director - Home Care - RN

    Aveanna HealthcareClark, NJ, US
    Full-time
    Aveanna is compassion and passion rolled into one inspired purpose.It’s anything you want to find and everything you’re looking for. It’s a place where caring is more personal beca...Show moreLast updated: 6 days ago
    • Promoted
    • New!
    Senior Manager, Clinical Data Management

    Senior Manager, Clinical Data Management

    Bristol-Myers SquibbPrinceton Junction, NJ, United States
    Full-time
    Those aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely interesting work happens every day, in every department.From optim...Show moreLast updated: 7 hours ago
    • Promoted
    Manager, Data Management

    Manager, Data Management

    Kyowa KirinPrinceton, NJ, US
    Full-time
    Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need : oncology, nephrology, imm...Show moreLast updated: 2 days ago
    • Promoted
    Senior Manager Clinical Study Lead (Cell Therapy)

    Senior Manager Clinical Study Lead (Cell Therapy)

    RegeneronWarren, NJ, US
    Full-time
    The Senior Clinical Study Lead (CSL) is expected to operate with a high degree of independence and is accountable for the global execution of assigned large and / or complex clinical trials from stud...Show moreLast updated: 2 days ago
    • Promoted
    RN - Telemetry (Interventional)

    RN - Telemetry (Interventional)

    Deborah Heart and Lung CenterBrowns Mills, NJ, US
    Full-time
    Position Summary : Utilizes the nursing process to provide and direct primary nursing care to patients with.Handles multiple demands and tasks simultaneously, demonstrating clinical problem solving ...Show moreLast updated: 27 days ago
    • Promoted
    • New!
    Healthcare Transformation Manager

    Healthcare Transformation Manager

    VirtualVocationsToms River, New Jersey, United States
    Full-time
    A company is looking for a Manager, Healthcare Transformation.Key Responsibilities Lead initiatives to transform healthcare delivery systems Collaborate with stakeholders to identify and impleme...Show moreLast updated: 10 hours ago
    • Promoted
    Client Delivery Manager

    Client Delivery Manager

    VirtualVocationsToms River, New Jersey, United States
    Full-time
    A company is looking for a Client Delivery Manager.Key Responsibilities Oversee and drive large, high-impact projects from initiation to completion, ensuring alignment with client and business ob...Show moreLast updated: 30+ days ago
    • Promoted
    Prin Clinical Data Manager

    Prin Clinical Data Manager

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    Love clinical data management? Bring that passion to Novartis!.This key Principal Clinical Data Scientist will be responsible and accountable for managing all Data Management deliverables at a cons...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Clinical Research Medical Director CRM

    Associate Clinical Research Medical Director CRM

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    Accountable for all country clinical / medical aspects associated with Development and prioritized research programs / trials by providing clinical strategic and tactical leadership as the Country Clin...Show moreLast updated: 5 days ago
    • Promoted
    Therapeutic Data Strategy Director

    Therapeutic Data Strategy Director

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    This position will be located at East Hanover, NJ site and will not have the ability to be located remotely.Please note that this role would not provide relocation and only local candidates will be...Show moreLast updated: 30+ days ago
    • Promoted
    (Senior) Clinical Development Medical Director

    (Senior) Clinical Development Medical Director

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    We're a team of dedicated and smart people united by a drive to achieve together".Are you passionate about shaping the future of clinical development and making a meaningful impact in Cardiovascula...Show moreLast updated: 30+ days ago
    • Promoted
    Global Head, Clinical Imaging and Analytics

    Global Head, Clinical Imaging and Analytics

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and op...Show moreLast updated: 30+ days ago
    • Promoted
    Clinical Development Medical Director - Cardiovascular & Metabolic

    Clinical Development Medical Director - Cardiovascular & Metabolic

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    As a Clinical Development Medical Director in Cardiovascular Renal & Metabolic, you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, ...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director, Global Clinical Operations Study Optimization

    Senior Director, Global Clinical Operations Study Optimization

    Daiichi Sankyo, Inc.Bernards, NJ, US
    Full-time
    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address dive...Show moreLast updated: 3 days ago